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Recruiting NCT02808572

New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients

No phase Interventional Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level, Vascular calcification score.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

Overview

To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

Interventions

  • Biological Plasma osteoprotegerin level
    dosage of plasma osteoprotegerin
  • Biological Plasma fibroblast growth factor 23 level
    dosage of plasma fibroblast growth factor 23
  • Procedure Vascular calcification score
    measurement of vascular calcification score by multidetection computerized tomography

Primary outcome measures

  • Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion [Time frame: 7 years after inclusion]
Secondary outcome measures (4)
  • Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion [Time frame: 7 years after inclusion]
  • Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion [Time frame: 7 years after inclusion]
  • Mortality [Time frame: 7 years after inclusion]
  • Kidney functions [Time frame: during the 7 year follow-up]

Eligibility criteria

Inclusion criteria

  • Patient who has signed the written consent form
  • Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy

Exclusion criteria

  • Pregnancy
  • Patient with chronic renal failure requiring dialysis therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 7 centers
  • AIDER — Montpellier
  • CHU Montpellier, Cardiology department — Montpellier
  • CHU Montpellier, Endocrinology department — Montpellier
  • CHU Montpellier, Intensive care unit — Montpellier
  • CHU Montpellier, Internal medicine department — Montpellier
  • CHU Montpellier, Nephrology department — Montpellier
  • AIDER — Saint-Jean-de-Védas

Identifiers

NCT: NCT02808572 · UF9125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗